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    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <reference>PC100-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:12.049Z</lastUpdated>
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    <udiDi>00816394020957</udiDi>
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    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z121799</emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC900-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:34:10.453Z</lastUpdated>
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    <udiDi>00816394021947</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLR118-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:30.654Z</lastUpdated>
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    <udiDi>00816394021992</udiDi>
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    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLR120-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:30.554Z</lastUpdated>
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    <udiDi>00816394022067</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLR125-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:30.438Z</lastUpdated>
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    <udiDi>00816394021930</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLR118-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:30.394Z</lastUpdated>
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    <udiDi>00816394021985</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLR120-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:30.253Z</lastUpdated>
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    <udiDi>00816394022050</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLR125-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:21.468Z</lastUpdated>
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    <udiDi>00816394021954</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iPR118-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:21.330Z</lastUpdated>
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    <udiDi>00816394022012</udiDi>
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    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iPR120-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:20.771Z</lastUpdated>
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    <udiDi>00816394022081</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iPR125-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:20.141Z</lastUpdated>
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    <udiDi>00816394021855</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR118-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:20.099Z</lastUpdated>
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    <udiDi>00816394022005</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR120-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:19.783Z</lastUpdated>
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    <udiDi>00816394022074</udiDi>
    <basicUdiDi>081639402TFR0116M</basicUdiDi>
    <tradeName>Horizon Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR125-GXC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:42:18.423Z</lastUpdated>
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    <udiDi>00816394020643</udiDi>
    <basicUdiDi>081639402TFR0036N</basicUdiDi>
    <tradeName>Quick Thaw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS THAWERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:41.404Z</lastUpdated>
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    <tradeName>Quick Thaw</tradeName>
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    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:41.392Z</lastUpdated>
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    <tradeName>Quick Thaw</tradeName>
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    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>BLOOD AND BLOOD COMPONENTS THAWERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:41.370Z</lastUpdated>
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    <tradeName>i.Series</tradeName>
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    <manufacturerName>Helmer Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF15-PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:41.305Z</lastUpdated>
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    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
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    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode></emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF48-PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:41.293Z</lastUpdated>
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    <udiDi>00816394020995</udiDi>
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    <tradeName>i.Series</tradeName>
    <deviceName></deviceName>
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    <manufacturerSrn>US-MF-000003326</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD TRANSFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF96-PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:41.277Z</lastUpdated>
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